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Generated: December 18, 2017

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Cysteamine bitartrate - Generic Drug Details

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What are the generic drug sources for cysteamine bitartrate and what is the scope of cysteamine bitartrate freedom to operate?

Cysteamine bitartrate
is the generic ingredient in two branded drugs marketed by Horizon Pharma Usa and Mylan, and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cysteamine bitartrate has thirty-five patent family members in twenty-five countries and six supplementary protection certificates in five countries.

There are five drug master file entries for cysteamine bitartrate. Three suppliers are listed for this compound.

Pharmacology for cysteamine bitartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
MylanCYSTAGONcysteamine bitartrateCAPSULE;ORAL020392-002Aug 15, 1994RXYesYes► Subscribe► Subscribe► Subscribe
Horizon Pharma UsaPROCYSBIcysteamine bitartrateCAPSULE, DELAYED RELEASE;ORAL203389-002Apr 30, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Horizon Pharma UsaPROCYSBIcysteamine bitartrateCAPSULE, DELAYED RELEASE;ORAL203389-001Apr 30, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Horizon Pharma UsaPROCYSBIcysteamine bitartrateCAPSULE, DELAYED RELEASE;ORAL203389-001Apr 30, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Horizon Pharma UsaPROCYSBIcysteamine bitartrateCAPSULE, DELAYED RELEASE;ORAL203389-002Apr 30, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Horizon Pharma UsaPROCYSBIcysteamine bitartrateCAPSULE, DELAYED RELEASE;ORAL203389-002Apr 30, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Horizon Pharma UsaPROCYSBIcysteamine bitartrateCAPSULE, DELAYED RELEASE;ORAL203389-002Apr 30, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Horizon Pharma UsaPROCYSBIcysteamine bitartrateCAPSULE, DELAYED RELEASE;ORAL203389-002Apr 30, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Horizon Pharma UsaPROCYSBIcysteamine bitartrateCAPSULE, DELAYED RELEASE;ORAL203389-002Apr 30, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Horizon Pharma UsaPROCYSBIcysteamine bitartrateCAPSULE, DELAYED RELEASE;ORAL203389-001Apr 30, 2013RXYesNo► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: cysteamine bitartrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,814,689Enterically coated cysteamine, cystamine and derivatives thereof► Subscribe
8,129,433Enterically coated cysteamine, cystamine and derivatives thereof► Subscribe
9,795,578Enterically coated cysteamine, cystamine and derivatives thereof► Subscribe
9,750,708Enterically coated cysteamine, cystamine and derivatives thereof► Subscribe
9,511,039Enterically coated cysteamine, cystamine and derivatives thereof► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: cysteamine bitartrate

Country Document Number Estimated Expiration
Hong Kong1218066► Subscribe
China105492000► Subscribe
European Patent Office2535044► Subscribe
Singapore11201510126Q► Subscribe
Argentina096628► Subscribe
Canada2938644► Subscribe
Japan2016523250► Subscribe
BrazilPI0707277► Subscribe
Portugal1919458► Subscribe
Eurasian Patent Organization023971► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: CYSTEAMINE BITARTRATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
4 50001-2014Slovakia► SubscribePRODUCT NAME: MERKAPTAMIN; FIRST REGISTRATION: EU/1/13/861, 20130906
/2014Austria► SubscribePRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
2014000023Germany► SubscribePRODUCT NAME: CYSTEAMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/861 20130906
2014 00013Denmark► SubscribePRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906
0649Netherlands► SubscribePRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
00649Netherlands► SubscribePRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130906
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Serving leading biopharmaceutical companies globally:

Accenture
McKinsey
Moodys
Boehringer Ingelheim
Teva
Chubb
Colorcon
Healthtrust
Citi
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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